Adherence and its measurement in phase 2/3 microbicide trials.

AIDS and Behavior
Elizabeth TolleyAriane van der Straten

Abstract

Adherence optimization and measurement have emerged as critically challenging issues for clinical trials of topical microbicides. Although microbicide trials have routinely collected adherence data, their utilization in trial design, implementation, and interpretation has been inconsistent. Drawing on data-driven presentations from several focused meetings, this paper synthesizes lessons from past microbicide trials and provides recommendations for future trials of microbicide and other HIV prevention technologies. First, it describes four purposes for adherence data collection, with particular attention to intention-to-treat versus adherence-adjusted analyses for determining effectiveness. Second, the microbicide field's experiences with adherence measures and data collection modes are discussed, including the strengths and weaknesses of various options and approaches for improving measurement. Then, several approaches to optimizing trial participants' adherence are presented. The paper concludes with a set of recommendations for immediate use or further research.

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Oct 14, 2011·Sexually Transmitted Diseases·Lauren L KatzenBarbara S Mensch
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Apr 9, 2013·Journal of the International AIDS Society·Cynthia WoodsongSheena McCormack
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Methods Mentioned

BETA
circumcision

Software Mentioned

IVR
Fem
ACASI
CAPRISA

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